GMP
Regulatory framework ensuring consistent product quality manufacturing
ISO 28000
International standard for supply chain security management systems
Quick Verdict
GMP ensures manufacturing quality for pharma and food via strict controls and inspections, while ISO 28000 builds supply chain security through risk management. Companies adopt GMP for regulatory compliance and patient safety; ISO 28000 for resilience and certification.
GMP
Good Manufacturing Practices (GMP)
Key Features
- Mandates independent Quality Control Unit oversight
- Prioritizes prevention over end-product testing alone
- Requires validated processes and equipment qualification
- Enforces comprehensive documentation and traceability
- Integrates Quality Risk Management principles
ISO 28000
ISO 28000:2022 Security management systems Requirements
Key Features
- Risk-based supply chain security assessment and treatment
- PDCA cycle for continual SMS improvement
- Top management leadership and policy commitment
- Supplier and third-party security governance
- Integration with ISO 22301 and 27001 standards
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
GMP Details
What It Is
Good Manufacturing Practices (GMP), including cGMP under FDA 21 CFR Parts 210/211 and EU EudraLex Volume 4, is a regulatory framework establishing minimum standards for manufacturing controls. It ensures products like pharmaceuticals are consistently produced to quality criteria through preventive, risk-based approaches across facilities, processes, and documentation.
Key Components
- **5 PsPeople, Premises, Processes, Procedures, Products.
- Pillars include quality management system (PQS), Quality Risk Management (QRM), validation, independent quality oversight, and continual improvement via CAPA.
- Built on ICH Q9/Q10; enforced via inspections, no formal certification but compliance mandatory.
Why Organizations Use It
Mandated for market access in pharma/biologics; prevents recalls, contamination; reduces liability; builds stakeholder trust. Strategic benefits: supply reliability, efficiency, global harmonization via PIC/S/ICH.
Implementation Overview
Phased: gap analysis, Validation Master Plan, training, qualification (IQ/OQ/PQ), audits. Applies to manufacturers globally; requires ongoing inspections, no central certification.
ISO 28000 Details
What It Is
ISO 28000:2022 is an international management system standard titled Security and resilience — Security management systems — Requirements. It provides a risk-based framework for establishing, implementing, maintaining, and improving a security management system (SMS) focused on supply chain protection against threats like theft, sabotage, and disruptions.
Key Components
- Core clauses: context, leadership, planning, support, operation, performance evaluation, improvement (PDCA-aligned).
- Emphasizes risk assessment, security policy, operational controls, supplier governance, incident response.
- Built on ISO High Level Structure for integration with ISO 9001, 22301, 27001.
- Optional third-party certification via accredited bodies per ISO 28003.
Why Organizations Use It
- Mitigates supply chain risks, reduces incidents, lowers insurance costs.
- Meets contractual/regulatory demands (e.g., C-TPAT equivalents), enhances trade facilitation.
- Builds stakeholder trust, competitive edge in logistics, manufacturing, pharma.
Implementation Overview
- Phased: scoping, gap analysis, risk assessment, controls deployment, audits.
- Scalable for SMEs to multinationals; 9-18 months typical.
- Involves training, supplier engagement, continual improvement.
Key Differences
| Aspect | GMP | ISO 28000 |
|---|---|---|
| Scope | Manufacturing quality controls, processes, facilities | Supply chain security risks, resilience |
| Industry | Pharma, biologics, food, cosmetics globally | Logistics, manufacturing, retail worldwide |
| Nature | Regulatory/enforceable standards, mandatory | Voluntary management system certification |
| Testing | Process validation, audits, inspections | Internal audits, risk assessments, certification |
| Penalties | Warning letters, recalls, fines | Loss of certification, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about GMP and ISO 28000
GMP FAQ
ISO 28000 FAQ
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